News In Brief
This article was originally published in The Silver Sheet
Executive Summary
FDA finally releases rule requiring electronic Medical Device Reporting; eReporting initiative for recalls struggles; and more.
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Adverse Event Reports Hit All-Time High; FDA Warns Firms About MDRs, Complaint Handling
As FDA sifts through almost a million Medical Device Reports submitted by manufacturers last year, the agency is trying to determine why so many adverse events are being reported. Isaac Chang, a director in CDRH’s Office of Surveillance and Biometrics, speculates that there could be a number of reasons for the large influx of MDRs, including high-profile recalls and a sharper FDA focus on human factors issues. Further, more than half of adverse events were reported to the agency on individual MedWatch forms in 2012 – a sharp increase over previous years. However, despite the extraordinary rise in reports, some firms continue to have trouble developing MDR procedures. Industry experts also weigh in on social media’s impact on adverse event reporting, and tips are shared for ensuring that complaints are properly handled by manufacturers.
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.
Hanmi-OCI Merger Hits Wall As Brothers Win Shareholder Vote, Board Seats
The planned merger of Korea's Hanmi Pharm Group with OCI Group hits a major speed bump as the two sons of Hanmi's founder and other candidates recommended by them secture board seats. But it remains to be seen how the Lim brothers will fulfil their ambitious promises.